4.4 Protocol Deviations When a deviation from the protocol is deemed necessary for an individual infant, the investigator or other responsible physician must contact study PI immediately, unless a delay would endanger the subject, so that a timely decision can be made as to whether or not the infant should be enrolled or continue in the study. The deviation from the protocol will be authorized only for that particular infant. A description of the departure from the protocol and the reason(s) for it must be recorded on the appropriate CRF. Additionally, sites will adhere to local IRB reporting rules for protocol deviations.